“Too expensive and Too Slow” – Drugs Still Lagging Behind?

The MHLW’s Clinical Trial Action Plan of 2008 aimed to reduce the drug lag by tackling two key complaints often aimed at Japanese clinical trials – that they were “too expensive” and “too slow”. Morunda KK recently approached a varied selection of Japanese clinical development professionals to get their thoughts on how the industry has improved since then. We approached professionals working for foreign-affiliated pharmaceutical manufacturers, domestic manufacturers, and CROs. Many people kindly took the time to complete our survey in English and leave their personal comments.

Read More

The good news is that the overwhelming majority of respondents (84.4%) feel that the industry has improved. One executive stated, “Just after the plan in 2008, the MHLW still had a very defensive position but, recently, we feel a great improvement in the thinking about globalization in clinical studies.” Overall though, the mood is best described as cautiously optimistic, with 68.8% of respondents believing the industry has “somewhat improved”, and significantly less (15.6%) feeling it has greatly improved. It is notable, though, that only 3.1% of respondents feel that the industry has improved very little.

So, in what ways has the industry improved? A clear majority (65.6%) feel that trials are “getting faster but are still too expensive”. Some respondents pointed out that their company data supports this evaluation, indicating a notable increase in speed and a small decrease in cost. The key factors accounting for the continued high cost were given as (a) SMO fees, (b) research fees to patients, and (c) the large number of fragmented outsourced vendors making many different payments necessary.

Since a large number of people feel that trials have become faster, what do they think has contributed to this? 50% of respondents feel that the PMDA has become more accepting of foreign data. Some respondents also feel that the PMDA has become faster in approval (one executive estimated that approvals are 20-30% quicker than in 2008), and more “consultative” i.e., more willing to interpret guidelines in an open manner and discuss issues openly with companies. Concerns do remain, however. Some feel that the PMDA continue to make too many “non-essential” or “non-valuable” enquiries during the CTA review, which slows the process.

When asked about clinical sites and outsourced functions, we continued to see a balance of pessimism and optimism. 40.6% feel that outsourced support functions have improved, and 37.5% believe that the infrastructure around clinical trials has improved, with specific mention being made of improvements in National Hospitals’ human resources. However, respondents specified two areas which still need to be keenly addressed: (a) productivity and patient-numbers at sites, and (b) the ability of CRCs and investigators to produce quality work independently of the Site Monitors.

With 65.6% of people stating that they feel trials are faster and cheaper, it is notable that the next most popular response in our survey (18.8%) was that trials are “still too slow and expensive compared to most countries”. Administrative concerns were consistently highlighted in this area. For example, the contract situation in Japan (contracts being made between hospital and client, rather than between investigator and client) adds difficulties. Respondents also pointed out that a lot of essential documents are required, and there are many processes involved in applying for sites and to Institutional Review Boards. In addition to this, a large number of support manuals have to be prepared even outside of the protocol and main manuals. Overall, many feel that this places too heavy a workload on the sponsor.

In summary, the MHLW and the industry have taken positive steps since 2008. As one executive commented, it is already possible for companies to aim for global standards through strategic and resourceful planning. Challenges remain, however, in improving the speed of clinical trials and, particularly, in reducing costs. In order to drive the next phase of improvements, it may be time for some bold thinking. McKinsey & Company Japan’s Dr Ludwig Kanzler notes that, “While we have seen significant improvement, we are probably hitting a plateau now or very soon, and further improvements will require more drastic measures.” The drive and leadership necessary for these next steps will need to come from the integrated efforts of all involved – manufacturers, vendors, the government, and healthcare professionals.

Morunda Asia

Talent Search

Morunda Blue

Retained Search

Connect with us

It was recently reported that three large Japanese pharmaceutical companies, Fujifilm, Takeda Pharmaceutical,

Read more >

A Commercial Mind “Generally medical doctors who work in hospitals have no idea about what we do in the compan

Read more >

An American Pharma company had spent many months and millions of yen retaining one of the world’s leading recruit

Read more >

The MHLW’s Clinical Trial Action Plan of 2008 aimed to reduce the drug lag by tackling two key complaints often a

Read more >

A Commercial Mind “Generally medical doctors who work in hospitals have no idea about what we do in the compan

Read more >

An American Pharma company had spent many months and millions of yen retaining one of the world’s leading recruit

Read more >